FDA Inspection 779868 — June Jacobs Labs, LLC
The FDA completed an inspection of June Jacobs Labs, LLC on May 16, 2012 in Moonachie, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Moonachie, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |